Diffuse Parenchymal Lung DiseasesMicrosemio-PINCT02961335
Validation of Alveolar Probe-based Confocal Laser Endomicroscopy Descriptors in Diffuse Parenchymal Lung Diseases
A study testing Bronchoscopy, Confocal microendoscopy and Biopsy sampling in people with Diffuse Parenchymal Lung Diseases, run by University Hospital, Rouen at 1 site in France.
Trial summary
Diffuse parenchymal lung diseases (DPLD) include a variety of respiratory conditions that affect either the pulmonary interstitium or the alveolar space . The etiological diagnosis of DPLD is often challenging, because of the large number of pathological entities involved, which share close clinical and radiological… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Parenchymal Lung Diseases
- What is being tested?
- Bronchoscopy, Confocal microendoscopy and Biopsy sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2018to 13 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18
- signed written informed consent
- indication for a flexible bronchoscopy
- DPLD characterized by clinical and radiological data compatible with : idiopathic pulmonary fibrosis (IPF), acute or chronic hypersensitivity pneumonitis (HPS), sarcoidosis, or asbestosis.
- Initial histological confirmation of the disease is not required for the inclusion of the patient and the realisation of the alveolar bronchoscopy.
- non-smoking or smoking cessation >6 month
- Patient affiliated with, or beneficiary of a social security category
Who cannot join
- respiratory failure and contraindication for a flexible bronchoscopy (this item will stay at the appreciation of the physician, arterial blood gaz sampling being not required)
- bleeding disorder which would be not compatible with the realization of a flexible bronchoscopy
- history of pneumonectomy or non functional lung controlateral to the pCLE procedure
- patients for which a per-endoscopic distal lung cryobiopsy is forecasted during the first diagnostic bronchoscopy,
- patients for which the bronchoscopy needs a general anesthesia and mechanical ventilation during the procedure
- anticoagulant or platelet aggregation inhibitors that cannot be interrupted for the flexible bronchoscopy
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- patients for which a follow up or an adequate work-up to achieve the final diagnosis will not be possible.
- patients for which a cryobiopsy is forecasted during the bronchoscopy
- pregnant and breast feeding women, or women of childbearing potential not taking adequate contraception
- Patients unable to understand informed consent
- Patient on major legal measure of protection
- Patients participating in an other interventional clinical trial at the inclusion date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Alveolar Probe-based Confocal Laser Endomicroscopy Descriptors in Diffuse Parenchymal Lung Diseases : A Multicentric Prospective Study
Diffuse parenchymal lung diseases (DPLD) include a variety of respiratory conditions that affect either the pulmonary interstitium or the alveolar space . The etiological diagnosis of DPLD is often challenging, because of the large number of pathological entities involved, which share close clinical and radiological presentations. High resolution Chest CT, a key diagnostic procedure in DPLD, is subject to significant inter-observer analysis variations, so that the diagnosis sometimes requires a surgical or transbronchial lung biopsy sampling. This invasive procedure is not devoid of morbidity and may be impossible to perform in fragile patients. Therefore, the definite diagnosis of DPLD is usually achieved following a multi-disciplinary expert consensus, based on careful medical history, chest CT and bronchoalveolar lavage examinations.
Alveolar probe-based confocal laser endomicroscopy (pCLE) is a mini invasive endoscopic technique that allows distal lung microscopic imaging in vivo, during a flexible bronchoscopy performed under topical anaesthesia. Since 2006, Alveolar pCLE has been used in a monocentric clinical trial at the Rouen University Hospital in more than 200 patients and healthy volunteers. This allowed the first pCLE in-vivo description of normal pulmonary acinus, and confirmed the safety of the technique.
- Conditions
- Diffuse Parenchymal Lung Diseases
- Being tested
- Bronchoscopy, Confocal microendoscopy, Biopsy sampling
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyProcedure or surgery
Patient who need to undergo bronchoscopy. During bronchoscopy, biopsy sampling and Confocal microendoscopy will be done
Confocal microendoscopyProcedure or surgery
Confocal microendoscopy will be performed during this initial bronchoscopy
Biopsy samplingProcedure or surgery
Patient who need to undergo bronchoscopy. During bronchoscopy, biopsy sampling and Confocal microendoscopy will be done
| Study group | Role | What they receive |
|---|---|---|
| Patient who need to undergo bronchoscopy | Experimental | Patient who need to undergo bronchoscopy. During bronchoscopy, biopsy sampling and Confocal microendoscopy will be done Receives: Procedure: Bronchoscopy; Procedure: Confocal microendoscopy; Procedure: Biopsy sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of confocal imaging (solid pattern) for the diagnostic of the pulmonary nodule
Confocal imaging will be considered as "positive" when both
- a solid pattern is displayed
- a diagnostic biopsy is obtained at the site of confocal imaging
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study start2 Dec 2018
- Primary completion13 Sep 2022
- Study completion13 Sep 2022
Why it stopped: Difficulty in enrolling new patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Parenchymal Lung DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc THIBERVILLE, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961335
- Sponsor's protocol ID
- 2014/0208/HP
- Acronym
- Microsemio-PI
- Status last verified
- Apr 2026
- First submitted
- 8 Nov 2016
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Alveolar Probe-based Confocal Laser Endomicroscopy Descriptors in Diffuse Parenchymal Lung Diseases : A Multicentric Prospective Study
- ClinicalTrials.gov ID
- NCT02961335
- Acronym / sponsor ID
- Microsemio-PI / 2014/0208/HP
- Conditions
- Diffuse Parenchymal Lung Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in enrolling new patients
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 2 Dec 2018 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 10 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diffuse parenchymal lung diseases (DPLD) include a variety of respiratory conditions that affect either the pulmonary interstitium or the alveolar space . The etiological diagnosis of DPLD is often challenging, because of the large number of pathological entities involved, which share close clinical and radiological presentations. High resolution Chest CT, a key diagnostic procedure in DPLD, is subject to significant inter-observer analysis variations, so that the diagnosis sometimes requires a surgical or transbronchial lung biopsy sampling. This invasive procedure is not devoid of morbidity and may be impossible to perform in fragile patients. Therefore, the definite diagnosis of DPLD is usually achieved following a multi-disciplinary expert consensus, based on careful medical history, chest CT and bronchoalveolar lavage examinations.
Alveolar probe-based confocal laser endomicroscopy (pCLE) is a mini invasive endoscopic technique that allows distal lung microscopic imaging in vivo, during a flexible bronchoscopy performed under topical anaesthesia. Since 2006, Alveolar pCLE has been used in a monocentric clinical trial at the Rouen University Hospital in more than 200 patients and healthy volunteers. This allowed the first pCLE in-vivo description of normal pulmonary acinus, and confirmed the safety of the technique.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient who need to undergo bronchoscopy | Experimental | Procedure: Bronchoscopy, Procedure: Confocal microendoscopy, Procedure: Biopsy samplingPatient who need to undergo bronchoscopy. During bronchoscopy, biopsy sampling and Confocal microendoscopy will be done |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age ≥ 18
- signed written informed consent
- indication for a flexible bronchoscopy
- DPLD characterized by clinical and radiological data compatible with : idiopathic pulmonary fibrosis (IPF), acute or chronic hypersensitivity pneumonitis (HPS), sarcoidosis, or asbestosis.
- Initial histological confirmation of the disease is not required for the inclusion of the patient and the realisation of the alveolar bronchoscopy.
Key exclusion criteria (12 listed)
- respiratory failure and contraindication for a flexible bronchoscopy (this item will stay at the appreciation of the physician, arterial blood gaz sampling being not required)
- bleeding disorder which would be not compatible with the realization of a flexible bronchoscopy
- history of pneumonectomy or non functional lung controlateral to the pCLE procedure
- patients for which a per-endoscopic distal lung cryobiopsy is forecasted during the first diagnostic bronchoscopy,
- patients for which the bronchoscopy needs a general anesthesia and mechanical ventilation during the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BronchoscopyPatient who need to undergo bronchoscopy. During bronchoscopy, biopsy sampling and Confocal microendoscopy will be done | Procedure or surgery | Patient who need to undergo bronchoscopy |
| Confocal microendoscopyConfocal microendoscopy will be performed during this initial bronchoscopy | Procedure or surgery | Patient who need to undergo bronchoscopy |
| Biopsy samplingPatient who need to undergo bronchoscopy. During bronchoscopy, biopsy sampling and Confocal microendoscopy will be done | Procedure or surgery | Patient who need to undergo bronchoscopy |
Primary outcome
Sensitivity of confocal imaging (solid pattern) for the diagnostic of the pulmonary nodule
Time frame: Day 1
Confocal imaging will be considered as "positive" when both * a solid pattern is displayed * a diagnostic biopsy is obtained at the site of confocal imaging
Results and safety
The study was stopped early (reason given: Difficulty in enrolling new patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc THIBERVILLE, Pr principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy, Confocal microendoscopy and Biopsy sampling in people with Diffuse Parenchymal Lung Diseases, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty in enrolling new patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of confocal imaging (solid pattern) for the diagnostic of the pulmonary nodule (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.